An Open-Label, Single-Arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy of Azacitidine, Chidamide, and PD-1 Monoclonal Antibody in the Treatment of Refractory/Relapsed Peripheral T-Cell Lymphoma.
Age ≥18 years and ≤75 years, male or female.
Histologically confirmed peripheral T-cell lymphoma (PTCL) by the investigating center, including: peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS); anaplastic large cell lymphoma (ALK-negative or ALK-positive); angioimmunoblastic T-cell lymphoma; enteropathy-associated T-cell lymphoma; NK/T-cell lymphoma; and other PTCL subtypes deemed eligible by the investigator.
Relapsed or refractory disease after at least one prior line of systemic therapy. Relapse is defined as disease recurrence after complete response (CR) or progression after partial response (PR) or stable disease (SD). Refractory disease is defined as progressive disease (PD) after 2 cycles of therapy, or SD after 4 cycles of therapy, or failure to achieve response after adequate last-line therapy (e.g., at least 2-3 cycles of systemic chemotherapy without remission), or progression during treatment.
Patients considered ineligible for autologous hematopoietic stem cell transplantation by the investigator, or those who refuse such treatment.
History of other malignancies within the past 5 years, except for those treated with curative intent (e.g., basal cell carcinoma of the skin, carcinoma in situ).
Patients with significant dysfunction of major organs.
Known involvement of central nervous system (CNS) lymphoma.
History of active bleeding or newly diagnosed thrombotic disease, or those with bleeding tendency receiving anticoagulant therapy.
Single group
Azacitidine (AZA)
DrugAzacitidine 100 mg is administered subcutaneously once daily from day 1 to day 7. The PD-1 monoclonal antibody 200 mg is administered by intravenous infusion on day 1. Chidamide 20 mg is administered orally twice weekly.
Objective Response Rate (ORR)
To evaluate the objective response rate (ORR) of azacitidine, chidamide, and PD-1 monoclonal antibody combination therapy in refractory/relapsed peripheral T-cell lymphoma.
Complete Response Rate (CRR)
To evaluate the complete response rate (CR rate) of azacitidine, chidamide, and PD-1 monoclonal antibody combination therapy in refractory/relapsed peripheral T-cell lymphoma.
Progression-free survival（PFS）
To evaluate the progression-free survival (PFS) rate of azacitidine, chidamide, and PD-1 monoclonal antibody combination therapy in refractory/relapsed peripheral T-cell lymphoma.
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